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Amgen (AMGN) and Cytokinetics (CYTK) announced The Lancet published results from a Phase 2 clinical trial evaluating omecamtiv mecarbil in patients with chronic heart failure. The COSMIC-HF trial met its primary pharmacokinetic objective and showed statistically significant improvements in all pre-specified secondary measures of cardiac function in the treatment group receiving pharmacokinetic-based dose titration. The results were initially presented as a Late-Breaking Clinical Trial at the American Heart Association Scientific Sessions 2015. The trial, which evaluated 448 patients with chronic heart failure and left ventricular systolic dysfunction, showed that dose titration controlled patient exposure to omecamtiv mecarbil. Patients were randomized 1:1:1 to receive either placebo or treatment with omecamtiv mecarbil dosed as 25 mg twice daily or 25 mg with dose escalation to 50 mg twice daily, depending on plasma concentrations of omecamtiv mecarbil after two weeks of treatment. The pharmacokinetic-based dose titration strategy was designed to maintain patient exposure to omecamtiv mecarbil in the targeted plasma concentration range. Approximately 53% of patients in the dose titration group were escalated to a dose of 50 mg twice daily. Adverse events, including serious AEs, in patients on omecamtiv mecarbil were comparable to placebo. The incidence of adjudicated deaths, myocardial infarction and unstable angina was similar. Other cardiac AEs were generally balanced between placebo and active treatment groups. In patients receiving omecamtiv mecarbil compared to placebo, cardiac troponin increased by 0.001 ng/mL and 0.006 ng/mL in the 25 mg twice daily group and dose titration group, respectively. Events of increased troponin were independently adjudicated and none were adjudicated as an episode of myocardial ischemia or infarction.

After Amgen's stock sunk 10% following its Q3 results, Argus says that the decline was triggered by "news that pricing power for Enbrel would be limited in 2017." However, the firm says that the company's growth outlook is "solid," while it has launched "promising new drugs." The firm keeps a Buy rating on the stock.

11/08/16

11/08/16INITIATION

On The Fly: Top five analyst initiations

Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Adient (ADNT) initiated with a Neutral at JPMorgan. 2. JinkoSolar (JKS) initiated with a Buy at Craig-Hallum. 3. Amgen (AMGN), Gilead (GILD), and Celgene (CELG) initiated with a Buy at Mizuho while the firm initiated Biogen (BIIB) with a Neutral. 4. BioScrip (BIOS) resumed with a Buy at Jefferies. 5. SQM (SQM) initiated with a Market Perform at BMO Capital. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.

11/09/16

PIPR

11/09/16NO CHANGEPIPR

Piper sees improving environment for Biopharma M&A

The biotech sector is seeing a "massive relief rally" given the "surprise trifecta" of a Republican sweep, the voting down of Prop 61 in California and U.S. dollar weakness, Piper Jaffray analyst Joshua Schimmer tells investors in a research note. The door is now open to discuss potential repatriation of cash outside the U.S., which could be a green light on mergers and acquisitions, the analyst adds. He points out that Amgen (AMGN) and Gilead (GILD) hold the most overseas cash, with Celgene (CELG) and Biogen (BIIB) holding several billion as well. Schimmer believes the broader environment may be improving for M&A. He cautions, though, that the election of Trump does not remove the "major drug pricing overhang question."

CYTKCytokinetics

$12.00

-0.35 (-2.83%)

12/16/15

PIPR

12/16/15NO CHANGETarget $24PIPROverweight

Cytokinetics price target raised to $24 from $17 at Piper Jaffray

Piper Jaffray analyst Charles Duncan raised its price target for Cytokinetics to $24 citing greater conviction in the company's pipeline assets ahead of its "busy" 2016. Piper views Cytokinetics as the leader in muscle-biology and reiterates an Overweight rating on the name.

06/21/16

FBRC

06/21/16NO CHANGETarget $24FBRCOutperform

FBR views Cytokinetics as attractive despite 36% rally

Even with shares up 36% since added to his firm's Alpha Generator list in March, FBR Capital analyst Vernon Bernardino still views shares of Cytokinetics (CYTK) as attractive for an initial investment. The analyst believes partner Amgen (AMGN) will exercise its option and advance omecamtiv mecarbil into Phase III testing in heart failure. Bernardino keeps an Outperform rating on the shares with a $24 price target.

Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Chesapeake Utilities (CPK) initiated with a Neutral at Ladenburg. 2. CONSOL (CNX) initiated with a Neutral at Goldman. 3. Johnson Controls (JCI) assumed with an Equal Weight at Barclays. 4. American Midstream Partners (AMID) initiated with a Buy at Janney Capital. 5. Brookfield Infrastructure (BIP) coverage resumed with an Outperform at Wells Fargo. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.

Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Abercrombie & Fitch (ANF) downgraded to Sell from Hold at Argus with analysts John Eade and Katelyn Bayone citing the company's third quarter miss and what they see as its "challenging sales outlook for the remainder of the year." 2. Duluth Holdings (DLTH) downgraded to Hold from Buy at Stifel and to Market Perform from Outperform at William Blair. 3. DAVIDsTEA (DTEA) downgraded to Market Perform from Outperform at BMO Capital and to Market Perform from Outperform at William Blair. 4. Hilton (HLT) downgraded to Outperform from Buy at CLSA with analyst Jon Oh citing valuation. 5. Horizon Pharma (HZNP) downgraded to Neutral from Buy at Mizuho. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.

Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. AstraZeneca (AZN) upgraded to Outperform from Market Perform at Leerink with analyst Seamus Fernandez saying the recent weakness in shares provides an "excellent entry point" ahead of several critical pipeline events that have the potential "to transform this giant into an exciting growth story." 2. Autodesk (ADSK) upgraded to Buy from Hold at Canaccord with analyst Richard Davis citing expectations for improved free cash flow, as he sees a path to $6 in FCF by 2020 and $11 per share in 2022. 3. Eaton (ENT) upgraded to Overweight from Neutral at JPMorgan with analyst Ann Duignan saying optionality of the company's balance sheet should offset broad weakness across its end markets. 4. Fluor (FLR) upgraded to Buy from Neutral at Citi with analyst Andrew Kaplowitz saying the company is positioned to outperform given amid oil and gas capex stabilization, a lift off the bottom in mining off the bottom and "muted" 2017 expectations. 5. Sysco (SYY) upgraded to Neutral from Sell at Goldman. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.